Chronic Constipation
Conditions
Keywords
chronic constipation, washed microbiota transplantation, antibiotic pretreatment, randomized controlled trial, transendoscopic enteral tube
Brief summary
This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study
Detailed description
All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, complete spontaneous bowel movements（CSBM), Constipation assessment scale (CAS), Patient-Assessment of Constipation Quality Of Life（PAC-QOL) and clinical outcomes were collected. After the treatment, the efficacy and safety were evaluated during the follow-up period.
Interventions
DRUGOrnidazole
Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days
DRUGPlacebo
Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days
Sponsors
Faming Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to enter the study: 1. Male and female, aged ≥18 years old, provided written informed consent; 2. Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions: 1\) spontaneous bowel movement frequency \<3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2. 3\. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of complete spontaneous bowel movements（CSBM） | One-week, Four-week and Eight-week post-WMT | Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance. |
| The extent of change observed in Constipation assessment scale (CAS) of participants | One-week, Four-week and Eight-week post-WMT | The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation. |
| The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants | One-week, Four-week and Eight-week post-WMT | The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The extent of change observed in stool properties of participants | One-week post-WMT | Bristol stool form scale(BSFS) was used, which can be divided into seven types. |
| Rate of Adverse Events | One-week, Four-week and Eight-week post-WMT | The rate of adverse events after antibiotic pretreatment |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui
Outcome results
None listed